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NCT Number: NCT01930370

Effect of Varied Dialysate Bicarbonate Levels on Phosphate and Potassium Removal

Modeling of bicarbonate within the dialysate fluid, specifically a lower than standard concentration has been suggested in facilitating the removal of phosphate and potassium. To test this hypothesis, the study will use a cross-over study design to evaluate phosphate and potassium removal during dialysis by altering bicarbonate concentration in dialysis fluid (i.e. high bicarbonate, standard bicarbonate washout, low bicarbonate), and compare the effects of the different dialysate bicarbonate concentrations on the removal of phosphate and potassium during hemodialysis

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

Elevation of blood phosphate levels in chronic dialysis patients is associated with increased mortality due to cardiovascular events, and if sustained leads to hyperactivity of parathyroid glands and renal bone disease. Similarly, increased calcium-phosphate product as a result of elevated levels of phosphate in the blood is an additional risk factor for vascular calcification. Elevated blood potassium levels is another major electrolyte disorder in patients with advanced renal disease which is potentially life threatening. Therefore control of blood phosphate and potassium levels is a fundamental component of treatment for end stage renal disease. Management of hyperelectrolyte levels in renal failure patients requires restriction of phosphate and potassium intake through dietary measures, promotion of excretion via GI tract through medication delivery (i.e. supplementary binders), and removal through dialysis. All these strategies come with limitations however, specifically adherence to dietary restrictions and medication compliance is poor due to lack of immediate repercussions, as well as the complex kinetics involved with removal via dialysis given the dependence on duration and frequency of dialysis whose manipulation is limited by time considerations for the patient and scheduling issues in the dialysis unit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 0-18 years old
  • Patients receiving maintenance hemodialysis* for a total of 9-15 hours per week
  • Pre-dialysis serum potassium value between 4.0 and 6.5 mmol/L on the first day of the treatment protocol
  • Pre-dialysis serum phosphate value greater than low normal for age on the first day of the treatment protocol
  • Pre-dialysis serum bicarbonate (total CO2) value between 18 and 30 mmol/L on the first day of the treatment protocol
  • Pre-dialysis corrected calcium value between 1.80-2.85 mmol/L on the first day of the treatment protocol

Exclusion criteria

  • Hemodynamically unstable patients (requiring inotropes or midodrine for support).
  • Pre-dialysis potassium value < 4.0 or > 6.5 mmol/L on the first day of the treatment protocol
  • Pre-dialysis serum phosphate value less than low normal for age on the first day of the treatment protocol (i.e. hypophosphatemia)
  • Pre-dialysis serum bicarbonate (total CO2) value <18 or > 30 mmol/L on the first day of the treatment protocol
  • Pre-dialysis corrected calcium <1.8 and >2.85 mmol/L on the first day of the treatment protocol
  • Patients mechanically ventilated
  • Drugs that could modify internal phosphate and potassium balance such as insulin, bicarbonate injection, hypertonic dextrose solution or mannitol infusion during HD

Treatment and study plan

Bicarbonate hemodialysis solution (low concentration)

Drug

One-week experimental session (3 dialysis treatments) with low dialysate bicarbonate (28 mmol/L)

Bicarbonate hemodialysis solution (high concentration)

Drug

One-week experimental session with high dialysate bicarbonate (38 mmol/L)

Primary outcomes

  1. Phosphate/Potassium Removal

    Time frame: Dialysis Treatment 1 (Day 1) - Pre and Post dialysis (0hrs and 4hours)

    The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):

    Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)

  2. Phosphate/Potassium Removal

    Time frame: Dialysis Treatment 2 (Day 2) - Pre and Post dialysis (0hrs and 4hours)

    The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):

    Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)

  3. Phosphate/Potassium Removal

    Time frame: Dialysis Treatment 3 (Day 3) - Pre and Post dialysis (0hrs, 4hours, 5hours)

    The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):

    Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)

  4. Phosphate/Potassium Removal

    Time frame: Dialysis Treatment 7 (Day 15) - Pre and Post dialysis (0hrs, 4hours)

    The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):

    Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)

  5. Phosphate/Potassium Removal

    Time frame: Dialysis Treatment 8 (Day 16) - Pre and Post dialysis (0hrs, 4hours)

    The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):

    Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)

  6. Phosphate/Potassium Removal

    Time frame: Dialysis Treatment 9 (Day 17) - Pre and Post dialysis (0hrs, 4hours, 5hours)

    The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):

    Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)

Secondary outcomes

  1. Plasma Phosphate Levels

    Time frame: Baseline and Post Dialysis (4hours)

    Measurement of the biochemical (serum) parameters of Phosphate for each dialysis treatment

  2. Plasma Potassium Levels

    Time frame: Pre and Post Dialysis

    Measurement of the biochemical (serum) parameters of Potassium for each dialysis treatment

  3. Total Plasma CO2 (bicarbonate)

    Time frame: Pre and Post Dialysis (0 and 4hours)

    Measurement of the biochemical (serum) parameters of CO2 (bicarbonate) for each dialysis treatment

  4. Corrected Calcium Measurement

    Time frame: Pre and Post Dialysis (0 and 4hours)

    Biochemical measurement of the blood for corrected caclium (calcium and albumin) for each dialysis treatment

  5. Dialysis Adequacy (Kt/ V)

    Time frame: Pre and Post Dialysis (0 and 4hours)

    Measurement of Blood urea will be performed for each dialysis treatment.

  6. Dialysis Adequacy (Urea Reduction Ratio -URR)

    Time frame: Pre and Post Dialysis (0 and 4hours)

    Measurement of Blood urea will be performed for each dialysis treatment.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Effect of Varied Dialysate Bicarbonate Levels on Phosphate and Potassium Removal: A Pilot Study

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 28, 2013
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.